On the shelf-life side it states that a 3 month real time test period can be used to extrapolate that it will be OK for 12 months of shelf life. This is probably the minimum that they will go for, given that trials could take that long.
I'm not sure how they test this. It could be some sort of molecular analysis or maybe repeating the initial toxicology tests after the 3 months is up.
Either way, it gives an indication of the ongoing work that needs to be done to support the paperwork for initiating trials.
I'm fine thanks. Looking forward to the next 12 months here.
We are in the final stages of Pre-Clinical development (both here for CHK1 and China for Aurora FLT3).
The main things to prove are detailed toxicology on aminals (more than just the mice which have been successfully tested on so far) and manufacture of the drugs in sufficient quantity and quality to be used on people (right down to packaging) and also shelf-life tests (does it degrade after a certain period of time). I'm not sure if these are running concurrently but given the high cost of this work it wouldn't suprise me.
Failure at any point would be market sensitive info and should be notified as soon as they know. But I doubt that we will be informed of each little success until all of the pre-clinical work is complete. He could say "we are 95% of the way through, just one little step to go" only for that little step to scupper the whole thing.
IMO we should get notified when pre-clinical is finished and the paperwork is submitted for trials to start. But for CHK1 and Aurora FLT3 that should be in the second half of this year.
Either one actually being used on people would be a great success. Both would be amazing. It's one of the benefits of SAR over other companies in my opinion.
But the question of funding the CHK1 trials remains. Shorter term, its a gamble. If Tim can deal on something else, it takes away this doubt. If he doesn't SAR will need to find over a million to pay for the trials (if the payment is similar to BACITs and probably is) which will not be kind to the SP.
Fingers crossed for a) Pre-Clinical success and then b) funding. Not necessarily in that order.
Regarding your post yesterday, would it not be beneficial for Sar to inform us as to how things are progressing throughout this period. Not sure as to what is considered the norm. (if it is allowed or not) Hope you are well, and keep up the good research work.
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